December 2018

FDA releases new strategic Framework for its Real World Evidence Program

Real World Data (RWD) is health data collected from outside the tightly controlled clinical trial setting. It provides greater insight into experiences with pharmaceutical products and devices at all stages, from research and development, to [...]

By WEP|2021-03-15T11:06:12+00:00December 14th, 2018|FDA|

FDA releases information on Right to Try on its website

The goal of the FDA is to ensure that patients can access needed medicines in a safe and compliant manner, and the agency will support any legislation that aims to further this. As such, although [...]

By WEP|2021-03-15T11:06:12+00:00December 5th, 2018|Expanded Access Programs, FDA, Legislation|